The overarching goal of the Biostatistics and Informatics (BI) Core is to provide high quality and state-of-the- art services in biostatistics and informatics to all research projects and data generating cores within the WNY Center for Research on Flavored Tobacco Products (CRoFT). The BI core will provide cost-efficient and centralized service for appropriate study design, data collection, secured data transfer, data quality control, data harmonization, database management, biostatistical and bioinformatical data analysis, results interpretation and reporting, as well as novel biostatistical and bioinformatical methods and tools development, and training. The core lead Dr. Li and two core co-investigators Drs. McCall and Yan have extensive experiences in biostatistics and bioinformatics, including study design, data collection, data quality control, cross-sectional and longitudinal data analysis, DNA methylation and gene expression data analysis, novel biostatistical and bioinformatical methods and tools development. The BI core will achieve the goal through the following specific aims: Aim 1: Study design support for ongoing and pilot projects. The BI core will provide support to rapid response and career enhancement pilot projects within CRoFT to ensure appropriate research design methods and adequate sample size resulted from power analysis. In addition, the BI core will advise investigators conducting longitudinal studies on procedure for minimizing attrition and maximizing participation. Aim 2: Data capture, quality assurance and harmonization. The BI core will set up a CRoFT database to capture all data generated from projects and cores, conduct data quality control procedures to ensure the high quality of the data, and conduct data harmonization through PhenX Toolkit to facilitate the data sharing across all Tobacco Centers of Regulator Science (TCORS). Aim 3: Statistical and bioinformatical data analysis, novel methods and tools development. The BI core will standardize biostatistical and bioinformatical methods and tools for genomic data analysis, provide epidemiological data analysis for identifying risks of emerging flavoring compounds associated with human health, and develop cutting-edge novel biostatistical and bioinformatical methods and tools for integrated data analysis across projects to categorize flavor risks. Aim 4. Statistical and bioinformatical methods and tools training. The BI core will promote dissemination of the novel biostatistical and bioinformatical methods and tools to all TCORS investigators through publicly accessible seminars, symposia, and workshops. The BI core will also partner with Administrative Core (AC) and Career Enhancement Core (CEC) and leverage the resources within the University of Rochester Clinical and Translations Science Institute to provide robust and centralized support to tobacco product regulator science.